DeviceClearance

Product code ELB— Dental

AIR BURBINE HANDPIECE-DENTAL SCALING

Classification name
Scaler, Rotary
Device class
Class 2
Regulation
21 CFR 872.4840
Advisory panel
Dental
Total cleared
6
First cleared
Most recent

Market context for product code ELB

FDA has cleared 6 devices under product code ELB between 1979 and 2017, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ELB

Recent clearances under product code ELB

Data sourced from openFDA. This site is unofficial and independent of the FDA.